Studie zur Vorbeugung von
Darmpolypen mit Grüntee-Extrakt

Blinding and randomization

Stratified randomization based on study centers and on regular intake of low-dose ASS (yes or no) will be performed with the software ROM [27] to achieve balance of these baseline covariates. There will be no further stratification, since it is assumed that with a sample size of n = 1203 per group for the ITT collective, covariates like green tea consumption, age, sex, family history of colon cancer, medication and lifestyle will be equally distributed in both study arms.

Recruitment will be competitive and concurrent in about 30 colonoscopy screening centers throughout Germany. It will be assumed that each study center will recruit at least 30 patients per year.

Patients and physicians including the study coordinators will be fully blinded to the study substance. An independent pharmaceutical contract manufacturer specializing in solid pharmaceutical dosing forms will produce the placebo and EGCG capsules, and will dispense them according to a randomization list. Patients included into the run-in phase will be notified by a fax to the study coordinating center.

Randomization will take place after a successful run-in period, and a random study number will be assigned to each participant. The study substance for the first three months (three packages containing 70 blistered capsules each) will then be sent out during one week after the end of the run-in period. Study start is the first day of intake of the study substance.

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